Medical device licence · 112110 · Class 3
LEOS CANNULATED SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 31, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112110
- Licence holder
- Tyber Medical, Llc.Bethlehem, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 31, 2024
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COUNTERSINK CANN HD SCREWS
- COUNTERSINK CANN HLESS SCREWS
- DEPTH GAUGE
- DRILL AO
- DRILL GUIDE CANN SCREWS
- DRILL INSERT CANN SCREWS
- DRILL LARGE AO
- K-WIRE
- K-WIRE DOUBLE END TROCAR TIP
- K-WIRE FLUTED TIP
- K-WIRE SINGLE END TROCAR TIP
- LEOS HD CANN SCREW, FT, TI
- LEOS HD CANN SCREW, LG, TI
- LEOS HD CANN SCREW, SH, TI
- LEOS HD CANN SCREW, TI
- LEOS HLESS CANN SCREW, LG, TI
- LEOS HLESS CANN SCREW, SH, TI
- LEOS HLESS CANN SCREW, TI
- OVERDRILL LARGE AO
- PARALLEL WIRE GUIDE CANN SCREWS
- TAP
- TISSUE PROTECTOR OUTER SLEEVE
- WASHER
- WIRE INSERT CANN SCREWS
- WIRE INSERT LEOS DRILL GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.